[Translation] A single-center, randomized, double-blind, placebo-controlled Phase Ib clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of DBM-1152A inhalation solution after multiple doses in healthy Chinese subjects

评价DBM-1152A吸入溶液多次吸入给药在中国健康受试者中的安全性和耐受性。评价DBM-1152A吸入溶液多次吸入给药在中国健康受试者中的药代动力学特征。评价中国健康受试者接受DBM-1152A吸入溶液多次给药后C-QTc关系。

[Translation]

To evaluate the safety and tolerability of multiple inhalation administration of DBM-1152A inhalation solution in healthy Chinese subjects. To evaluate the pharmacokinetic characteristics of multiple inhalation administration of DBM-1152A inhalation solution in healthy Chinese subjects. To evaluate the C-QTc relationship after multiple administration of DBM-1152A inhalation solution in healthy Chinese subjects.

Start Date14 Aug 2024

Sponsor / Collaborator

Beijing Showby Pharmaceutical Co Ltd

[+1]

CTR20234060 / CompletedPhase 1

评价DBM-1152A吸入溶液在中国健康受试者中单次给药的一项随机、双盲、单中心、安慰剂对照、剂量递增的安全性、耐受性和药代动力学的Ⅰa期临床研究

[Translation] A randomized, double-blind, single-center, placebo-controlled, dose-escalating Phase Ia clinical study to evaluate the safety, tolerability, and pharmacokinetics of a single-dose inhalation solution of DBM-1152A in healthy Chinese subjects

(1) 考察DBM-1152A吸入溶液单次吸入给药在中国健康受试者体内的安全性和耐受性； (2) 考察DBM-1152A吸入溶液单次吸入给药在中国健康受试者体内的药代动力学特征； (3) 探索性评估中国健康受试者使用DBM-1152A吸入溶液后的C-QTc关系。

[Translation]

(1) To investigate the safety and tolerability of a single inhalation of DBM-1152A inhalation solution in healthy Chinese subjects; (2) To investigate the pharmacokinetic characteristics of a single inhalation of DBM-1152A inhalation solution in healthy Chinese subjects; (3) To exploratory evaluate the C-QTc relationship of healthy Chinese subjects after using DBM-1152A inhalation solution.

Start Date19 Dec 2023

Sponsor / Collaborator

Beijing Showby Pharmaceutical Co Ltd

[+1]

CTR20222611 / CompletedPhase 2

评估101BHG-D01鼻喷雾剂治疗感冒引起的流涕的有效性和安全性的多中心、随机、双盲、安慰剂、平行对照II期临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled, parallel-controlled Phase II clinical study to evaluate the efficacy and safety of 101BHG-D01 nasal spray in the treatment of runny nose caused by colds

主要目的：评价101BHG-D01鼻喷雾剂治疗感冒引起的流涕的有效性。次要目的：（1）评价101BHG-D01鼻喷雾剂治疗感冒引起的流涕、鼻塞、喷嚏的安全性。（2）评价101BHG-D01鼻喷雾剂对感冒引起的鼻塞、喷嚏的改善情况。

[Translation]

Primary objective: To evaluate the effectiveness of 101BHG-D01 nasal spray in treating runny nose caused by cold. Secondary objectives: (1) To evaluate the safety of 101BHG-D01 nasal spray in treating runny nose, nasal congestion and sneezing caused by cold. (2) To evaluate the improvement of 101BHG-D01 nasal spray in treating nasal congestion and sneezing caused by cold.

Start Date22 Nov 2022

Sponsor / Collaborator

Beijing Showby Pharmaceutical Co Ltd

100 Clinical Results associated with Beijing Showby Pharmaceutical Co Ltd

0 Patents (Medical) associated with Beijing Showby Pharmaceutical Co Ltd

Literatures (Medical) associated with Beijing Showby Pharmaceutical Co Ltd

01 Sep 2023·European Journal of Pharmacology

Effects of 101BHG-D01, a novel M receptor antagonism, on allergic rhinitis in animal models and its mechanism

Article

Author: Shen, Huijuan ; Jiang, Junxia ; Shen, Jian ; Xie, Qiangmin ; Wei, Hao ; Dai, Haibin ; Li, Yanyou ; Chen, Xiaoping ; Jia, Yongliang ; Xie, Yicheng ; Yao, Hongyi

Allergic rhinitis (AR) is a nasal mucosal disease with sneezing and nasal itching as the main symptoms. Although AR treatment continues to improve, there remains a lack of effective drugs. There are still controversies regarding whether anticholinergic drugs can effectively and safely relieve the symptoms of AR and reduce inflammation in the nasal mucosa. Here, we synthesized 101BHG-D01, which is a novel anticholinergic drug that mainly targets the M3 receptor and may reduce the adverse effects of other anticholinergic drugs on the heart. We evaluated the effects of 101BHG-D01 on AR and investigated the potential molecular mechanism of anticholinergic therapy for AR. We found that 101BHG-D01 effectively alleviated AR symptoms, reduced the infiltration of inflammatory cells and attenuated the expression of inflammatory factors (IL-4, IL-5, IL-13, etc.) in various AR animal models. In addition, 101BHG-D01 reduced the activation of mast cells and the release of histamine from rat peritoneal mesothelial cells (RPMCs) challenged by IgE. Moreover, 101BHG-D01 reduced the expression of MUC5AC in IL-13-challenged rat nasal epithelial cells (RNECs) and human nasal epithelial cells (HNEpCs). Furthermore, IL-13 stimulation significantly increased JAK1 and STAT6 phosphorylation, which was suppressed by 101BHG-D01. We demonstrated that 101BHG-D01 reduced mucus secretion and inflammatory cell infiltration in the nasal mucosa, which may occur through a reduction in activation of the JAK1-STAT6 signaling pathway, indicating that 101BHG-D01 is a potent and safe anticholinergic therapy for AR.

01 Jul 2022·European Journal of Drug Metabolism and PharmacokineticsQ4 · MEDICINE

Safety, Tolerability, and Pharmacokinetic Study of 101BHG-D01 Nasal Spray, a Novel Long-Acting and Selective Cholinergic M Receptor Antagonist, in Healthy Chinese Volunteers: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation, First-In-Human Study

Q4 · MEDICINE

Article

Author: Zhang, Lin ; Huang, Kai ; Ding, Ying ; Sun, Zhan-Guo ; Gu, Xiang-Hong ; Que, Lin-Ling ; Chen, Xiao-Ping ; Wang, Jia-Kun ; Chu, Nan-Nan ; He, Qing

BACKGROUND AND OBJECTIVE101BHG-D01 nasal spray is the first novel long-acting cholinergic M receptor antagonist under development to treat rhinorrhea in rhinitis. This first-in-human study aimed to evaluate the safety, tolerability, and pharmacokinetics of 101BHG-D01 nasal spray following single intranasal doses in healthy Chinese subjects.METHODSA randomized, double-blind, placebo-controlled, single-dose escalation study was conducted in healthy Chinese volunteers after intranasal doses of 101BHG-D01 nasal spray or placebo ranging from 40 µg to 960 µg (total of six doses). Blood samples were collected at scheduled time points, and plasma concentrations were determined using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. A non-compartmental method was used to calculate the main pharmacokinetic parameters, including the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC_0-t), the area under the plasma concentration-time curve from time zero to infinity (AUC_0-∞), the maximum plasma concentration (C_max), the time to maximum plasma concentration (T_max), and the elimination half-life (t_1/2). Safety was evaluated by monitoring adverse events, laboratory assays, vital signs, physical examinations, 12-lead electrocardiograms (ECGs), anterior rhinoscopy, ophthalmic examination, and ambulatory ECG monitoring.RESULTSFollowing single intranasal dosing, 101BHG-D01 was rapidly absorbed with a median T_max of 0.34-0.50 h and eliminated slowly with a mean t_1/2 ranging from 4.29 to 46.76 h for different dose groups. The C_max and AUC of 101BHG-D01 increased linearly across the examined dose range of 40-960 µg. 101BHG-D01 nasal spray was well tolerated, all AEs were mild, and no serious adverse events occurred during the study.CONCLUSIONS101BHG-D01 nasal spray was safe and well tolerated in healthy Chinese subjects when administered intranasally in single escalating doses. The mean C_max and AUC increased proportionally to the studied dose. The pharmacokinetic, safety, and tolerability profiles of 101BHG-D01 nasal spray indicate that it is a good candidate for further development as a treatment for rhinorrhea in rhinitis.

Frontiers in Pharmacology

Pharmacokinetics, metabolite profiling, safety, and tolerability of inhalation aerosol of 101BHG-D01, a novel, long-acting and selective muscarinic receptor antagonist, in healthy Chinese subjects

Article

Author: Gao, Huaye ; Ding, Li ; Li, Jintong ; Cui, Gang ; Sun, Zhanguo ; Chen, Xiaoping ; Cheng, Minlu

101BHG-D01 is a novel, long-acting, selective muscarinic receptor antagonist for the treatment of chronic obstructive pulmonary disease (COPD). A single-site, randomized, double-blind, placebo-controlled and dose-escalation study of 101BHG-D01 inhalation aerosol was conducted to evaluate its pharmacokinetics, metabolite profiling, safety and tolerability following the single inhaled doses ranged from 20 to 900 μg in healthy Chinese subjects. After inhalation, 101BHG-D01 was absorbed rapidly into plasma with the time to maximum concentration about 5 min, and eliminated slowly with the terminal phase half-life about 30 h. The cumulative excretion rates of 101BHG-D01 in feces and urine were about 30% and 2%, respectively, which showed the study drug was mainly excreted in feces. The maximum drug concentration and area under the plasma concentration-time curve increased with dose escalation in the range of 20–600 μg, but their values increased out of proportion to the whole studied doses. The main metabolic pathways were loss of phenyl group and hydroxylation. No metabolite that presented at greater than 10 percent of total drug-related exposure was observed. 101BHG-D01 was safe and well tolerated after administration. The study results indicate that 101BHG-D01 is a good candidate for the treatment of COPD and enable further clinical development in subsequent studies in patients.Clinical Trial Registration:http://www.chinadrugtrials.org.cn; Identifier: CTR20192058.

100 Deals associated with Beijing Showby Pharmaceutical Co Ltd

100 Translational Medicine associated with Beijing Showby Pharmaceutical Co Ltd

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Pipeline Snapshot as of 05 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

101BHG-D01 ( M3 receptor )	Common Cold More	Phase 2
JKN-23041	Pulmonary Disease, Chronic Obstructive More	Phase 2
DBM-1152A ( mAChRs x β2-adrenergic receptor )	Bronchial Spasm More	Phase 1
Bencycloquidium Bromide ( M1 receptor x M3 receptor )	Pulmonary Disease, Chronic Obstructive More	Phase 1
Pt(0506)101 ( BAX x Bcl-2 )	Gastroesophageal junction adenocarcinoma More	IND Approval

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